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Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05638542
Collaborator
(none)
582
Enrollment
1
Location
105
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The chromosomal instability (CIN) pathway, the CpG island methylator phenotype (CIMP) pathway and the microsatellite instability (MSI) pathway are three major carcinogenesis pathways to colorectal cancer (CRC). In this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and CRC and compare their molecular progression according to patients' sex and tumor location as well as disease stage.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    582 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
    Actual Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Jan 30, 2021
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Control group

    Patients who are not diagnosed with colorectal adenoma or colorectal cancer
    Colorectal adenoma group

    Patients who are diagnosed with colorectal adenoma
    Colorectal cancer group

    Patients who are diagnosed with colorectal cancer

    Outcome Measures

    Primary Outcome Measures

    1. The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC [through study completion, an average of 1 year]

      Using endoscopically biopsied specimens, multiple carcinogenic markers were investigated including KRAS and BRAF mutation, PD-L1, EGFR, IL-1b, NLRP3, Caspase-1, p53 expression, Microinstability (MSS, MSI-L, MSI-H), PD-L1, DNA mismatch repair proteins (MLH1, MSH2, MSH6, PMS2), CIMP markers (p16, MINT1, MINT2, MINT31, hMLH1), promoter methylation of p16, RUNX3, NEUROG1. CIMP was assessed by methylation-specific PCR for five methylation panel markers (p16, MINT1, MINT2, MINT31, hMLH1), and MSI status was validated by PCR using five NCI markers (BAT-26, BAT-25, D5S346, D17S250, and S2S123). KRAS and BRAF mutation was analyzed by direct sequencing using sequence-specific primers from the acquired biopsy specimens. PD-L1, EGFR, MMR expression was examined using immunohistochemistry.

    2. Fecal microbiota analysis in patients with colorectal adenoma and CRC [through study completion, an average of 1 year]

      Using next-generation sequencing technique, fecal microbiota of patients with colorectal adenoma and CRC as well as healthy control was evaluated to verify carcinogenesis-related microbiota.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Control group: subjects with no evidence of colorectal adenoma or colorectal cancer

    • Colorectal adenoma group: Patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma.

    • Colorectal cancer group: Patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma

    Exclusion Criteria:

    • Subjects age under 18 years

    • Previous history of colorectal neoplasms

    • Patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents

    • Denial to participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital

    Investigators

    • Study Chair: Nayoung Kim, M.D., Ph.D, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nayoung Kim, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT05638542
    Other Study ID Numbers:
    • B-1305-203-009
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nayoung Kim, Professor, Seoul National University Bundang Hospital
    Carcinogenesis
    Sex difference
    Tumor location
    Additional relevant MeSH terms:
    Adenoma
    Carcinogenesis

    Study Results

    No Results Posted as of Dec 6, 2022